A Confirmatory Trial of SK-PC-B70M in Mild to Moderate Alzheimer's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01249196
Recruitment Status : Completed
First Posted : November 29, 2010
Last Update Posted : November 26, 2013
Information provided by (Responsible Party):
SK Chemicals Co.,Ltd.

Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of SK-PC-B70M in patients with mild to moderate Alzheimer's disease.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: SK-PC-B70M Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 256 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : May 2010
Primary Completion Date : August 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: SK-PC-B70M
for dosage
Experimental: SK-PC-B70M 200mg bid Drug: SK-PC-B70M
for dosage
Experimental: SK-PC-B70M 300mg bid Drug: SK-PC-B70M
for dosage
Donepezil Drug: SK-PC-B70M
for dosage

Primary Outcome Measures :
  1. ADAS-cog (Alzheimer's Disease Assessment Scale-cognitive subscale) [ Time Frame: 30 minutes ]

Secondary Outcome Measures :
  1. CIBIC-Plus (Clinician's Interview-Based Impression of Change-Plus caregiver input) [ Time Frame: 45 minutes ]
  2. MMSE (Mini Mental State Examination) [ Time Frame: 10 minutes ]
  3. CDR-SB (Clinical Dementia Rating Sum of Box) [ Time Frame: 20 minutes ]

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Clinical diagnosis of probable Alzheimer's disease(DSM-IV and NINCDS-ADRDA criteria)
  • MRI within the last 12 months consistent with a diagnosis of AD
  • MMSE score of 10 to 26 and CDR of 1 or 2
  • AChEI or memantine was not taken at least 3 months prior to screening

Exclusion Criteria:

  • Other central nervous disease
  • Hypothyroidism, Vitamin B12/ Folic acid deficiency, Hypercalcemia, Neurosyphilis, AIDS
  • T.I.A or Major infarction within the last 12 months
  • Any serious disorder that could limit the ability of the patient to participate in the study
  • COPD or asthma
  • Any condition which would make the patient or the caregiver, in the opinion of the investigator, unsuitable for the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01249196

Korea, Republic of
SKChemicals invetigational site
Seoul, Korea, Republic of
Sponsors and Collaborators
SK Chemicals Co.,Ltd.

Responsible Party: SK Chemicals Co.,Ltd. Identifier: NCT01249196     History of Changes
Other Study ID Numbers: SMART_AD_III_2009
First Posted: November 29, 2010    Key Record Dates
Last Update Posted: November 26, 2013
Last Verified: November 2010

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders